Cryoport, Inc the world’s leading temperature-controlled logistics solutions company dedicated to the life sciences industry, announced the launch of its Advanced Therapy Shipper™ product line for the regenerative medicine market.
The Advanced Therapy Shipper™ guarantees each shipper has been used only for human use and provide complete traceability of all equipment, components and commodities. The result is unmatched verification information and unmatched supply chain support for biopharma companies researching and commercializing cell and gene therapies.
Cryoport’s new line of Advanced Therapy Shippers™ have been launched following strong client demand and in anticipation of more stringent government regulations. This first of their kind Cryoport Express™ shipper reduces the potential risk of cross contamination of materials during use, delivery and distribution of biopharmaceutical materials supporting advanced cell and gene therapies.
In addition to a fully segregated shipper fleet, the Cryoport Express™ Advanced Therapy ShipperTM line is the first in the industry to employ fully validated cleaning processes which reduce external contaminants on all equipment by 99.9999%. The Advanced Therapy Shipper™ line is the latest in Cryoport’s Chain of Compliance™ solutions, providing complete traceability of historical contents and providing reassurance to clinical and commercial advanced therapy sites requiring certification that any and all equipment has been used for clinical trials and commercial materials only.
Jerrell Shelton, Cryoport CEO, said, “Having signed 62 new biopharma customers since the beginning of the year, Cryoport has earned and enjoys a strong leadership position in the market for temperature-controlled logistics solutions for the cell & gene industry. Today’s introduction of our new Cryoport Express™ Advanced Therapy Shippers™ further widens the gap between Cryoport and any would-be competitors. These revolutionary Cryoport Express™ Shippers extend our market leading Chain of Compliance™ solution by providing complete traceability of, not only the respective commodity history of shipments, but of the historical use, performance, handling, cleaning and disinfection of all equipment and components as well. At Cryoport, we endeavor to stay close to the market and as the cell and gene therapy market matures, we expect regulations will continue to become more rigorous in recognition of the complex manufacturing methods for cellular and gene therapies. As always, our cutting-edge solutions ensure our clients that they are always one step ahead of these changes to minimize any potential disruption to their business.”
As part of the Company’s Chain of Compliance™ solution, Cryoport’s Advanced Therapy Shipper™ fleet will:
- Ensure use only for cell and gene therapies, containing human clinical trial and commercial materials
- Be segregated from other shipper fleets and processes
- Ensure all shipper components and materials maintain defined standards to ensure protection from cross-contamination
- Contain a new and validated cleaning and disinfection process resulting in a 6-log reduction of tested biological indicators
- Provide certification that each shipper is dedicated for advanced cell and gene therapy use
- Integrate into the Cryoportal® Logistics Management Platform to prevent violation of procedures and prevent cross contamination
- Assure that each dewar is requalified after each use for physical suitability, cleanliness, LN2 capacity, and shipment hold times.
Cryoport Express™ Advanced Therapy ShippersTM are validated to ISTA 3A and 7E Transportation Standards and include a new vapor plug that further de-risks shipments by doubling the holding time of mis-orientated shippers during transit.
About Cryoport, Inc.
Cryoport, Inc is the world’s premier provider of temperature-controlled logistics solutions for the life sciences industry, serving the Biopharma market. Our mission is to support life and health on earth by providing reliable and comprehensive solutions for the life sciences through our advanced technologies, Global Supply Chain Network and dedicated scientists, technicians and supporting team of professionals. Through purpose-built proprietary packaging; information technology; smart, sustainable cold chain logistics; and biostorage/biobanking services, Cryoport helps its customers advance life sciences research and deliver vaccines, medicines, IVF treatments and life-saving advanced therapies in over 100 countries around the world. For more information, visit www.cryoport.com